NCT01752270

the Effect of Diane-35 Pretreatment on In-vitro Fertilization Outcome for Patients With Polycystic Ovary Syndrome

The Effect of Diane-35 Pretreatment on Endocrine and Clinical Profile for Patients With Polycystic Ovary Syndrome Undergoing In-vitro Fertilization

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Polycystic Ovary Syndrome is the most common endocrine disorder in women, is estimated to affect more than 5% of the population and is associated with chronically elevated serum androgen concentrations.Evidence suggests that polycystic ovary syndrome has a negative impact on pregnancy outcomes, with an increased risk of gestational diabetes, hypertensive disease during pregnancy,and preterm birth,which is partially related with the hyperandrogenic environment.Diane-35 has been proved to be the most effective anti-androgenic drug.At present, there is no direct evidence that Diane-35 has a positive effect on the clinical outcome of polycystic ovary syndrome patients undergoing In-vitro fertilization/Intracytoplasmic sperm injection.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Diane-35 pretreatment	Diane-35 is applied from the third day of menstrual cycle for 21 days with a 7-day interval, for 3 consecutive cycles.
DRUG	Diane-35 pretreatment

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-12-01
• Completion: 2014-12-01
• First posted: 2012-12-19
• Last updated: 2012-12-19

Locations

2 sites across 1 country: China